PSY179 - IMPACT ANALYSIS OF THE PHARMACEUTICAL COVERAGE EXPANDING POLICY FOCUSED ON ANTICANCER & RARE DISEASE IN KOREA

Abstract

In Dec 2006, the Positive List System was introduced to reimburse only for new drugs with therapeutic and economic value recognized through reimbursement review of HIRA. Continuous negative decision for several anticancer drugs with high unmet need but insufficient clinical evidence and unacceptable cost-effectiveness, cause public demand for improvement of PLS. As a result, the government implemented the supplementary coverage expanding policies from late 2013. This study aims to analyze the impact of the Policies of Expanding Coverage on reimbursement decision-making. 705 cases with reimbursement decision-making completed by HIRA from 2008 to 2017 were analyzed. The policies of expanding coverage targets anticancer and rare disease drugs with improved clinical effectiveness. The flexible ICER threshold (Nov 2013), risk sharing scheme (Jan 2014), and the economic evaluation exemption scheme (May 2015) were introduced in turn. We analyzed the reimbursement rate by dividing into 1 period (2008∼2013), 2 period (2014∼2015), and 3 period (2016∼2017) according to introduction period of the scheme. The reimbursement rate of new drugs was 68% (482/705 cases) for 10 years. According to the three periods, risk-sharing scheme were applied to 1, 10 and 17 cases, economic evaluation exemption scheme to 0, 2 and 13 cases, respectively. All accepted cases with risk-sharing scheme were also applied flexible ICER threshold. While the reimbursement rates of anticancer and rare disease drugs were 40%, 49%, 81% and 60%, 82%, 84%, the others were 63%, 88%, 84%, respectively in the three periods. The policies of expanding coverage implemented in Korea show to have had a substantial positive impact on access of high unmet need drugs. However, recent advent of soaring price of new drugs triggers difficulty in reimbursement review and need for new plan to handle financial impact.